FDA.reportPublic FDA data

Instant Hand Sanitizer

Product NDC
57337-083
Requested package NDC
57337-083-01
11-digit product format
573370083
Labeler code
57337
Product ID
57337-083_2d761e9e-68bf-ffae-e063-6294a90ac509
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International Corp.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-04-25
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57337-08357337-083-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-08357337-083-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-08357337-083-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Instant Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e04fa70-c25d-4499-e054-00144ff8d46cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-083-012025-02-06C16284748780-12cef2736-a4d6-d83d-e063-dadaa90ab31fInstant Hand Sanitizer
57337-083-012025-01-30C16284748780-12cef2736-a4d6-d83d-e063-dadaa90ab31fInstant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-083-01Instant Hand Sanitizer53 mL in 1 BOTTLEGEL533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-083INSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL CORP.]3Current NDC, Legacy NDC, 1 package rows20250209_4e04fa70-c25d-4499-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 50 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DeeyeoDISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.45b33db6-13b4-5e28-e063-6294a90a6ea12025-12-11WarningsExact identifier
application number: M003
DEYODISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.b147ed5b-ab6e-ca00-e053-2a95a90ae01a2025-12-10WarningsExact identifier
application number: M003
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC1ea56ac9-4fc2-41c0-adda-5a2c55bef6962025-12-10WarningsExact identifier
application number: M003
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC847b9edc-74e6-43fd-83cd-43e6712780c62025-12-10WarningsExact identifier
application number: M003
The Pharma-C Company 70 Isopropyl Alcohol PadsISOPROPYL ALCOHOLKleen Test Products Corporationc5df867b-1b8d-4e38-8c32-7d528b9825902025-12-09WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.bf399508-bd29-0d90-e053-2995a90a067f2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb351a-06fb-8222-e053-2a95a90aadbf2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcead234-bb98-1ee8-e053-2a95a90a31862025-12-06WarningsExact identifier
application number: M003
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.acfdfa78-69e7-27dc-e053-2a95a90a85482025-12-06WarningsExact identifier
application number: M003
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb9358-663c-3c70-e053-2995a90a35242025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced08e7-a0bc-1328-e053-2995a90afb262025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcec13da-586c-6e7e-e053-2a95a90a6cd12025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceced03-eeb8-fced-e053-2995a90afd5c2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
application number: M003
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
application number: M003
2XL Mega Rolls Sanitizing WipesBENZALKONIUM CHLORIDE2xl Corporation9da541ab-6836-4149-a86d-3b2f2e5866282025-12-05WarningsExact identifier
application number: M003
Hand WipesBENZALKONIUM CHLORIDEAdvanced Ultrasound Solutions Inc.2c2abaa8-c152-470b-a4d9-5056815a19872025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3d95355-3af7-43e3-e053-2a95a90a0fa42025-12-05WarningsExact identifier
application number: M003
Giant Eagle Antibacterial Hand WipesBENZALKONIUM CHLORIDEGiant Eaglee20e9a93-03c3-77f8-e053-2995a90ae59f2025-12-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN4e04fa70-c25d-4499-e054-00144ff8d46c3
581660ethanol 0.62 ML/ML Topical GelSCD4e04fa70-c25d-4499-e054-00144ff8d46c3
581660ethanol 62 % Topical GelSY4e04fa70-c25d-4499-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-083-015733700830153 mL in 1 BOTTLE (57337-083-01) 53 ml2017-04-250000-00-00NoNoCurrent